The Supreme Court Friday asked the central government to discuss with states all facets of a legal framework to regulate and monitor clinical trials of new drugs by foreign firms across India. A bench of Justice R.M.Lodha and Justice Madan B. Lokur also asked petitioner Swasthya Adhikar Manch, the National Human Rights Commission (NHRC), NGOs and other organisations to submit their suggestions for strengthening the legal regime to regulate clinical trials so as to minimise the harm to the patients upon whom the new drugs were being tested.
The court asked the union health secretary to call a meeting of the chief secretaries/health secretaries of the states and union territories and report to it on the outcome as it directed the next hearing Sep 24. The court’s order came on a public interest litigation by Swasthya Adhikar Manch of Indore and others who sought a halt to ‘unethical’ clinical trials by multinational drug companies of their new products in India and treating of Indian patients as guinea pigs.
Complimenting the NGO and others for focusing on the issue, Justice Lodha said: ‘Your efforts have brought some changes. They (government) have become conscious of difficulties or the problems people are facing.’ Noting that the central govenment has taken some measures to strengthen the mechanism to regulate the clinical trials, the court said: ‘What we are interested in is that what has happened in the past should not get repeated. Arrest the recurrence of death and side effects because of clinical trials.’